At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 39 enrolled
Drug / intervention
Optisondrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Open-Label, Non-Randomized, Multicenter Study to Evaluate Safety and Efficacy of Intravenous Administration of OPTISON™ for Contrast- Enhanced Echocardiography in Pediatric Patients
In Brief
A Phase 4 clinical trial evaluating Optison for Transthoracic Echocardiography and Suspected or Known Structural or Functional Cardiac Abnormality. Completed, enrolled 39 participants across 8 sites.
Detailed Summary
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTransthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
CountriesUnited States
CollaboratorsLaboratory Corporation of America
Timeline
Phase 4CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartDec 2020
Primary CompletionMar 2023
TodayJul 2026
First PostedNov 14, 2018
Enrollment StartDec 1, 2020
Primary CompletionMar 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.6 years ago
Interventions
Optisondrug
Optison is administered intravenously